Impact of Whey Protein Supplementation on Body Composition, Energy Expenditure and Biochemical Parameters of Patients Submitted to Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Body Weight variation
研究概览
简要总结
Obesity is a metabolic disorder, characterized by an increase in the body's fat mass, which will reflect an increase in total body weight. In Brazil, overweight accounts for 53.8% of the population, and of these 18.9% are obese. Surgical treatment is currently the most successful method for weight loss in patients with Grade III obesity and reduced associated morbidities. The general objective is to evaluate genetic, inflammatory, and dietary factors that would influence weight loss and the appearance of protein deficiency or sarcopenia in patients undergoing bariatric surgery and to evaluate the effects of protein supplementation for 8 weeks after the 18th postoperative month in the parameters evaluated. The study has a randomized, placebo-controlled, double-masked model. The patients will be selected in two bariatric surgery services accredited by the Brazilian Health Unic System (SUS) in the city of Belo Horizonte, Brazil.
The project has already been approved by the Brazilian Ethics committee CONEP/UFMG by nº. 75415317.8.0000.5149. Patients of both sexes over 20 years of age will be included, attending the hospitals of the project with regular follow-up in the postoperative period. Data on anthropometry, body composition, muscle strength, energy expenditure, and inflammatory profile will be collected. The data will be correlated with the evaluation of the presence of genetic polymorphisms.
详细描述
Specific objectives:
It is also objective to evaluate:
- To observe the food consumption between 18 and 24 months of surgery with respect to protein and caloric intake;
- Evolution of weight loss, lean mass, fat mass and metabolic rate before and after supplementation with WP or placebo;
- Changes in protein status (assessed by muscle strength and serum levels of total protein, albumin, prealbumin, ferritin, hemoglobin) before and after supplementation with WP or placebo
- The inflammatory blood profile (assessed by cytokine levels and before and after supplementation with WP or placebo).
- The influence of the rS9939609 polymorphism of the FTO gene on the nutritional status, biochemical and inflammatory parameters in the postoperative (after 18 months) of surgery;
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Patient will receive indistinguishable sachets containing 30g of maltodextrin (placebo) or 30g whey protein. The sachets codification and patient allocation will be prepared by an individual without any contact with patients or the team which will follow patients
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients of both sexes over 20 years of age
- •Patients with regular follow-up in the postoperative period.
排除标准
- •Patients with debilitating chronic diseases
- •Severe vomiting
- •Submitted to other surgical procedures before 18 months of surgery
- •Patient with prostheses
- •Use or introduction of drugs immunosuppressants or affecting metabolism
结局指标
主要结局
Body Weight variation
时间窗: 8th week
measured in scale presented in kg
Muscle mass
时间窗: 8th week
measure by portable US
次要结局
- SNP (FTO) detection(1st week)
- Serum albumin(8th week)
- Resting metabolic rate(4th week)
- Body Weight variation(4th week)
- Muscle mass(4th week)
研究者
Jacqueline Isaura Alvarez Leite
Full Professor
Federal University of Minas Gerais